Institutional Review Board (IRB)
Instructions for Informed Consent Form (ICF) Template
You should use this consent form template only if:
1. You are conducting research on adults (18 years of age or older) and
2. Your research poses no greater than minimal risk to participants.
If you are conducting research that poses greater than minimal risk, you will need to specify
this in the section on Risks and include the section on Policies and Procedures for Researchrelated Injuries.
You should not use this consent form template if: you are doing research with minors.
Risk level is assessed in view of potential harms to participants – these include social, legal,
emotional, psychological etc. harms, not just physical harms. Depending on the subject matter
with which the research deals and the specific way in which the research is carried out, a study
may be considered greater than minimal risk even when using survey or interview (including
focus group) methodologies.
Note: According to DHHS Regulations “minimal risk” means: “The probability and magnitude
of harm or discomfort anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests.”
This template is intended to serve as a GUIDE. You may need to provide more information and
details than are stated in the template. You will most likely need to re-word sentences and/or add
your own sentences. You may also need to add information or details that are not directly asked
for in the template. Again, this template is intended to serve as a GUIDE and is not exhaustive.
REMEMBER: THE CONSENT FORM SHOULD CONTAIN ONLY INFORMATION THAT IS APPLICABLE
AND RELEVANT TO YOUR STUDY.
IMPORTANT: You should remove the red guidance text as you go through this document, by filling out
information specific to your study and/or deleting irrelevant and unnecessary text. The red sentences indicate
sections that must be completed by the author of the Consent Form, or serve as guidance and suggestions
about what should be included. There should be no red sentences left anywhere in the completed Consent
Form.
PLEASE PROOF READ your completed Consent Form before submitting it. Seemingly minor
spelling, grammar, and formatting errors may require you to revise and re-submit, causing
unnecessary delays.
PLEASE DO NOT INCLUDE these instructions in your completed Consent Form.
Department of (Name)
INFORMED CONSENT FORM
FOR PARTICIPATION IN A RESEARCH PROJECT
PROJECT TITLE: (Title)
PRINCIPAL INVESTIGATOR: (PI’s name)
MENTOR: (Mentor’s name) Include only if PI is a student.
SPU SPONSOR: (Sponsor’s name) Include only if PI is not directly affiliated with SPU.
INTRODUCTION
You are invited to consider participating in this research project. Please take as much time as you
need to make your decision. Feel free to discuss your decision with whomever you wish, but
remember that the decision to participate, or not to participate, is yours. If you decide to
participate, please sign and date where indicated at the end of this form.
PURPOSE
The purpose of this research is to (the reason(s) the research is being conducted, including what
the results will be used for).
PROJECT PLAN
You are being asked to take part in this research because you are (who? or hold what position? or
have what expertise? Identify the target population of the study). About (how many) subjects will
take part in this research.
If you decide to participate in this research, you will (Describe fully what participant will be
expected to do or take part in. Explain the procedures and schedule, focusing on what the subject
will be expected to do, e.g. complete surveys, questionnaires, interview, etc.).
The research will be looking at (the research topic/subject as well as the general types of
questions. Do not list specific questions. However, be sure to mention whether the research deals
with issues that might be considered sensitive or controversial, e.g. sexual behavior, drug or
alcohol use, other illegal activities etc.).
The (research session or sessions) will take place (when and where?).
If one session:
You will be in the project for about (anticipated duration of the session).
If multiple sessions:
You will be in the project for about (anticipated duration of subject involvement from start to
finish). Each session should last (anticipated duration of one session).
If applicable: You will also be contacted for follow-up (at what point? State when in the future
participants will be contacted and how).
(If the research involves videotaping or audio recording, mention this here. If so, indicate
whether being recorded is a requirement for participation; in the next paragraph, please provide
specific, separate information about recording storage & destruction)
If there are additional components to the research plan, please be sure to include them in this
section.
RISKS
There are (amount, e.g. no, minimal, very few, few, a number of) risks associated with
participating in this research.
If there are any risks whatsoever, include the following:
It is possible, but (probability, e.g. unlikely), that this research could cause (harm, e.g.
embarrassment, distress, employer problems) if (circumstance that could cause risk, e.g. others
learn of your responses, you have a strong emotional reaction to [topic], your employer finds out
and is unhappy).
Make sure to consider all types of risks, including physical, psychological, emotional, social,
economic, and legal risks. (Possible examples: embarrassment if private information about you
is accidentally disclosed to others, emotional distress from having to answer personal questions,
criminal or civil liability, etc.)
(For each risk, include: The researcher will try to reduce this risk by (state steps taken to
mitigate specific risk).)
BENEFITS
If you agree to take part in this research, there will be no direct benefit to you. However,
information gathered in this research may (reasonable result, e.g. provide insight into [topic] or
help us understand [topic]).
(If applicable: State any alternative procedures or treatments that may be of greater benefit to
the participant).
CONFIDENTIALITY
Please revise this entire section to make it applicable to your project.
Every effort will be made to keep any information collected about you confidential. However, it
is impossible to guarantee absolute confidentiality.
In order to keep information about you safe, (steps that will be taken to protect data, e.g. data
will be kept in a password-protected file on the researcher’s personal computer which only the
researcher can access, study data will be kept in a locked box at the researcher’s office etc.).
Include additional information, as listed below, on how different types of data will be kept
secure.
This section should include a description of:
a) What data will be kept and in what form (e.g. digital, paper – each type of data should
have its own distinct safety plan),
b) Whether the data will be identifiable (e.g. linked through a code, directly linked to
participant names etc.),
c) Where and how data will be securely stored (e.g. password-protected computer, locked
filing cabinet etc.),
d) Who will have access to the data,
e) Whether identifiable data will be shared outside the researcher team (if so, with whom,
how and why),
f) Whether (and if so, how and when) identifiers will be destroyed.
Revise or delete as applicable to this project:
We would like to include your name in the (final goal, e.g. thesis, publication, essay,
presentation) that result(s) from this research project. We want to (level of identification, e.g.
identify, describe) you for attribution and explanatory purposes. However, you have the option
not to have your name used when data from this research are published; if this is the case, please
(procedure, e.g. indicate so on the last page of this form, etc.). Please note that, even if your
name is not used in publication, the researcher (if applicable: and the research team) will still be
able to connect you to the information gathered about you in this research.
If there are any psychological or physical risks to participants, include this section. If there are
no such risks, do not include this section:
POLICIES AND PROCEDURES FOR RESEARCH-RELATED INJURIES
Researchers will make every effort to prevent research-related injuries and illnesses. If you are
injured or become ill while you are in the study, you will receive emergency medical care. The
costs of this care will be charged to you or to your health insurer. No funds have been made
available by Saint Peter’s University or its affiliates, or any government agency, to compensate
you for a research-related injury or illness.
YOUR RIGHTS AS A RESEARCH PARTICIPANT
Participation in this research is entirely voluntary. You can choose not to participate at all, or to
withdraw at any point. If you decide not to participate, or to withdraw, there will be no penalty or
loss of benefits to which you are otherwise entitled, or any effect on your relationship with the
researcher(s), or any other negative consequences. To be used for SPU student participants only:
Your participation or refusal to participate will have no effect on the grade you receive in any
course or your standing at Saint Peter’s University.
If you decide that you no longer want to take part in this research, you are encouraged to inform
the researcher of your decision. Please include/revise the following as applicable to your project:
The information already obtained through your participation (will/will not) be included in the
data analysis and final report for this research.
QUESTIONS OR CONCERNS
If you have questions about this research project, you may contact (PI’s Name) at (phone
number) or (email address). (If applicable: You may also contact the researcher’s faculty mentor,
(Mentor’s Name) at (phone number) or (email address). Please contact the Saint Peter’s
University IRB at 201 761-6137 or pcvek@saintpeters.edu if you have any questions about your
rights as a research participant.
STATEMENT OF PERSON OBTAINING INFORMED CONSENT
I have fully explained this research to the participant. I have discussed the purpose and
procedures, the possible risks and benefits, and that participation in this research is completely
voluntary. I have invited the participant to ask questions and I have given complete answers to
all of the participant’s questions.
______________________________________________
Signature of Person Obtaining Informed Consent
____________________
Date
STATEMENT OF CONSENT
I understand all of the information in this Consent Form. I have gotten complete answers for all
of my questions. I freely and voluntarily agree to participate in this research project. I understand
that I can withdraw at any time. My signature also indicates that I am 18 years of age or older
and that I have received a copy of this consent form.
_________________________________________
Participant Signature
____________________
Date
__________________________________________
Printed Name of Participant
Once you sign this form, you will receive a copy of it to keep and the researcher will keep
another copy.
NOTE ADDITIONAL CONSENT REQUIREMENTS.
PLEASE ADD IF APPLICABLE TO YOUR RESEARCH PROJECT
If subjects will be photographed/videotaped/audio recorded/etc. include (otherwise delete):
I understand that I will be (photographed/videotaped/audio recorded/etc.) as a part of this
research.
Please indicate whether you agree to be (photographed/videotaped/audio recorded/etc.) as a part
of this research.
 YES
(If you change your mind about this at any point, please let the researcher know)
 NO
If participants have the option to choose whether or not their names are used when data from
this study are published, include (revising as necessary) otherwise delete:
Please indicate whether you agree to have your full name If applicable: as well as your
(organization’s name/ job title/etc.) used alongside your comments in the final
(publication/presentation/essay/etc.) that result from this research.
 YES
(If you change your mind about this at any point, please let the researcher know)
 NO
 ALTERATION:
Name or pseudonym to be used: _____________________________________________
_________________________________________
Participant Signature
__________________________________________
Printed Name of Participant
____________________
Date